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Recent, research has focused on the evaluation of non-invasive methods for the assessment of liver fibrosis in patients with chronic liver disease. Among these methods, transient elastography is the most promising. The method has been investigated mainly in patients with viral hepatitis. Several studies have shown, that the optimal cut-off value of TE for detection of liver cirrhosis by transient elastography is highly dependent on the aetiology of the underlying liver disease. Only a few studies have evaluated the value of transient elastography for patients with autoimmune liver disease and here primarily patients with PBC and PSC. For patients with autoimmune hepatitis the data is limited. We prospectively investigated the diagnostic accuracy of TE in autoimmune hepatitis compared to liver histology with and without inclusion of the macroscopic appearance using mini-laparoscopy
The aim of the current study was to assess the diagnostic performance of transient elastography for the determination of cirrhosis in patients with autoimmune hepatitis compared to the diagnosis of cirrhosis made on Laparoscopic guided liver biopsy. Patients referred for liver biopsy and transient elastography with a clinical diagnosis of AIH followed in the liver clinic of the Department of Gastroenterology at the UKE were prospectively included in the study.
Inclusion criteria were as follows: Confirmed diagnosis of AIH based on the diagnostic criteria revised by the International Autoimmune Hepatitis Group 2008 (20): 1. liver related autoantibodies, 2. hypergammaglobulinaemia, 3.typical histological findings and 4. absence of viral markers. Exclusion criteria were morbid obesity (BMI > 40), ascites, ileus or subileus, peritonitis, pregnancy, extrahepatic cholestasis and a severe inflammatory flare of AIH.
Blood liver tests including gamma-globulines, IgG, IgM, liver related autoantibodies (ANA, AMA, LKM, SMA, SLA) and viral markers (HBsAg, Anti HBs, Anti HBc, Anti HCV, Anti HAV) were performed before LB.
Each patient underwent abdominal ultrasound to exclude extrahepatic cholestasis prior to TE and minilaparoscopic liver biopsy. TE and minilaparoscopy were performed by physicians blinded to the results the other within a period of less than 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transient elastography and liver biopsy | Other | All patients with Autoimmune hepatitis (AIH) were investigated with Transient Elastography before liver biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transient elastography (TE) | Device | TE and minilaparoscopic guided liver biopsy were performed by physicians blinded to the results the other within a period of less than 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis | The aim of the current study was to assess the diagnostic accuracy (Sens., Spec.) of transient elastography for the determination of cirrhosis in patients with autoimmune hepatitis. TE was compared to the diagnosis of cirrhosis made on histology yielded by laparoscopic guided liver biopsy. | Transient Elastography compared to liver histology |
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Inclusion Criteria:
Confirmed diagnosis of AIH based on the diagnostic criteria revised by the International Autoimmune Hepatitis Group 2008 (20):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrike W Denzer, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Ansgar W Lohse, MD | Universitätsklinikum Hamburg-Eppendorf | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Gastroenterology and Hepatology, University Medical Center Hamburg Eppendorf | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
Thirty-nine patients with AIH were eligible during the study period. Five patients were excluded: 4 patients due to ineffective or incomplete (<60% success rate) liver stiffness measurement, and 1 patient with a severe acute flare of AIH with markedly elevated liver enzymes."
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| ID | Title | Description |
|---|---|---|
| FG000 | Transient Elastography and Liver Biopsy | Transient elastography was performed by two experienced investigators using a FibroScan (EchoSens, Paris, France), the median value of liver stiffness measurements was recorded in kilopascals (kPa). Liver biopsy was carried out within 3 months of TE. Liver biopsies from the right and left lobe were obtained under laparoscopic control using the Tru-cut 16 GAUGE needle (Bard monopty; Bard biopsy systems, Tempe, USA). Data analysis was performed on the remaining 34 patients (female: 28 (82%); male: 6 (18 %). Indications for liver biopsy and Transient elastography were: 19 patients for follow-up of AIH while receiving immunosuppression and 15 patients for staging and grading of AIH before starting with an immunosuppressive therapy in. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Data analysis was performed on 34 patients (female: 28 (82%); male: 6 (18 %). Indications for liver biopsy and Transient elastography were: 19 patients for follow-up of AIH while receiving immunosuppression and 15 patients for staging and grading of AIH before starting with an immunosuppressive therapy in.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Study | Alle patients received a liver biopsy and Transient elastopgrapy for follow-up of Autoimmune Hepatitis or staging and grading of Autoimmune hepatitis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis | The aim of the current study was to assess the diagnostic accuracy (Sens., Spec.) of transient elastography for the determination of cirrhosis in patients with autoimmune hepatitis. TE was compared to the diagnosis of cirrhosis made on histology yielded by laparoscopic guided liver biopsy. | Sensitivity, specifity; Positive and negative predictive value of TE for diagnosis of cirrhosis was analyzed. | Posted | Number | Probability | Transient Elastography compared to liver histology |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TE in Autoimmune Hepatitis | Alle patients received a liver biopsy and Transient elastopgrapy for follow-up of Autoimmune Hepatitis or staging and grading of Autoimmune hepatitis. There were no adverse events. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain after liver biopsy | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PD Dr. Ulrike Denzer | Universitiy Clinic Hamburg eppendorf | 040741055380 | u.denzer@uke.de |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D019693 | Hepatitis, Autoimmune |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| Liver biopsy | Other | Minilaparoscopic guided liver biopsy was performed within a period of 3 months of Transient Elastography |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| Bleeding after liver biopsy | Hepatobiliary disorders |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |